New Fibromyalgia Drug

FDA APPROVES ANOTHER FIBROMYALGIA DRUG

Another new drug has recently been approved by the U.S. Food and Drug Administration (FDA) to treat the symptoms of Fibromyalgia. This antidepressant class drug is called Savella®. It joins the drugs Lyrica® and Cymbalta® that have earlier been FDA approved to treat the pain of this condition. Fibromyalgia is a chronic and debilitating condition that causes widespread pain throughout the fibrous tissues and muscles of the body. A decreased level of physical function often occurs. According to the American College of Rheumatology, over 6 million Americans suffer from its effects.

In the past 2 years, three different pharmaceutical companies have gotten into treating the symptoms of Fibromyalgia and received FDA approval to market their drugs in the United States. The first of these was by Pfizer Inc.’s Lyrica that was approved in June 2007. Previously, Lyrica was used in the treatment of seizures and for pain due to diabetes-induced nerve damage.
The drug’s side effects can include sleepiness, dizziness, blurry vision, weight gain, concentration problems, allergic reactions and dry mouth.

Just one year later in June 2008, Cymbalta from Eli Lilly and Company was FDA approved. It was previously used to treat depression, anxiety and diabetic peripheral neuropathy (nerve damage). The side effects of this drug include sleepiness, constipation, decreased appetite and nausea. Additionally, for people who suffer from depression, Cymbalta may increase the risk of
suicidal thinking. This could be dangerous to a person with Fibromyalgia as some with the disorder are also depressed, points out the FDA.

Now Savella from Forest Laboratories in the U.S. and the Pierre Fabre group (the 2nd largest independent pharmaceutical laboratory in France) was just approved by the FDA in January. This product falls into a class of drugs known as selective serotonin and norepinephrine dual reuptake inhibitors that claim to work on the neurotransmitters of the brain to reduce pain.

Testing of the product involved 2,000 people where the drug’s results were compared to a placebo for 3 months. At least half of the sample taking the drug said their pain reduction was only 30 percent. However, some of the effects of the drug were less than positive. The most frequently occurring adverse reaction was nausea.

Additional side effects reported in smaller numbers were constipation, hot flush, vomiting, palpitations, increased heart rate, dry mouth and hypertension.

Another very negative effect is that suicidal thinking also seems to increase when people take Savella. This is most prevalent in persons under 24 years of age and usually occurs during the first few weeks that a person begins taking the drug. As a result, this prescription drug will bear the same “black box warning” as antidepressants regarding the increased risk of suicidal
thinking and behavior in children, adolescents and young adults.

What has happened here with the drug companies is very simple. These organizations have identified a 6 million person market that needs help with a physical problem. What is there? Find a drug that can be trotted in front of the FDA, gain quick approval and start the cash register ringing as people think they have found help. In reality, all they have truly received is another
mask for their symptoms.

Natural healthcare professionals can help Fibromyalgia sufferers by using gentle treatments of the back and spine to increase the efficiency of the nervous system. Many chiropractors and acupuncturists will also focus on diet and nutrition, recommending healthy foods and urging people to reduce fats, proteins and hydrogenated oils.

Sources: The U.S. Food and Drug Administration. “Living with Fibromyalgia, Drugs Approved to Manage Pain.” http://www.fda.gov/consumer/updates/fibromyalgia062107.
html. Forest Laboratories. “Forest and Cypress Announce FDA Approval of Savella for the Management of Fibromyalgia.” January 2009.
http://www.frx.com/news/PressRelease.aspx?ID=1244788
HEALTH REPORTS
Vol. 13 Issue 44